JOURNEY LVAD: JOURNEY Left Ventricular Assist Device

Official title

Transcatheter Therapy to Treat Aortic Regurgitation in the Presence of a Left Ventricular Assist Device

Overview

The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve regurgitation (AR).

Interventions

• Device J-Valve Transfemoral System
  Treatment includes using the J-Valve Transfemoral (TF) System, a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device and Loading Accessories, during transcatheter aortic valve replacement (TAVR). The Edwards 16Fr eSheath+ Introducer Set may be used for the introduction and removal of the J-Valve TF System.

Primary outcome measures

• Primary Effectiveness Endpoint [Time frame: 30 days]
• Primary Safety Endpoint [Time frame: 30 days]

Secondary outcome measures (3)

• Valve embolization [Time frame: During index procedure]
• Need for second bioprosthetic valve [Time frame: During index procedure]
• Change in cardiovascular-specific health status [Time frame: 30 days compared with baseline]

Eligibility criteria

Inclusion criteria

• Adult with durable left ventricular assist device (LVAD) support and clinically significant AR (grade 4 or higher as assessed by core lab using TTE and adjunct TEE, if necessary) leading to LVAD dysfunction
• Symptomatic according to New York Heart Association (NYHA) functional class II or higher
• High risk for surgery as judged by a multi-disciplinary heart team
• Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)
• Written informed consent and agreement to comply with all required follow-up visits at investigational site

Exclusion criteria

• Prior aortic valve replacement or repair
• Aortic valve stenosis > moderate as assessed by core lab
• Severe mitral valve or tricuspid valve regurgitation as assessed by core lab
• Severe mitral valve or tricuspid valve stenosis as assessed by core lab
• Active infection requiring current antibiotic therapy, including infective endocarditis
• Cardiac imaging evidence of cardiac mass, thrombus or vegetation
• Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy
• Renal insufficiency (eGFR <25 mL/min/1.73m2) or end stage renal disease requiring chronic dialysis
• Cirrhosis (Child-Pugh Class B or C)
• Leukopenia (WBC <3000 cells/mcL), thrombocytopenia (platelet count <50,000 cells/mcL), anemia (hemoglobin <9 g/dL), history of bleeding diathesis, coagulopathy, or hypercoagulable state (unless therapeutically stable)
• Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media which cannot be adequately premedicated
• Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12 months post-index procedure
• Acute myocardial infarction within 30 days prior to index procedure
• PCI within 30 days prior to index procedure
• Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention
• Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure
• Uncontrolled atrial fibrillation
• Severe right ventricular (RV) dysfunction or chronic inotrope support (>30 days)
• Severe pulmonary hypertension (systolic pulmonary artery pressure >80 mmHg measured by right heart catheterization)
• Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home oxygen
• Stroke (cerebrovascular accident, CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure
• Estimated life expectancy of less than 12 months
• Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
• Participation in another investigational study that has not reached its primary endpoint
• Considered to be part of a vulnerable population

Anatomic Exclusions:

• Ascending aortic diameter ≥5.5 cm as assessed by core lab
• Aortic annulus perimeter <57 mm or >104 mm as assessed by core lab
• Inappropriate anatomy for femoral introduction and delivery of the study system
• Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy as assessed by core lab
• Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk
• Excessive aortic valve prolapse or leaflet deterioration that would preclude proper seating of the implant in the aortic annulus
• Abdominal/thoracic aortic aneurysm ≥5.0 cm as assessed by core lab
• Aorto-iliac disease requiring intervention to facilitate delivery of access sheath
• Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, and/or LV-aortic root angle >80°

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07363473 · JCM-003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗